Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study

NCT00947037 | Withdrawn Phase 2 DMC

• 1 other identifier: IN 12 005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

An extension of study IN 09 004 testing the long term safety of the Accordion Pill Carbidopa/Levodopa (AP-CD/LD)

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• To assess patient and investigator global evaluation of, and degree of satisfaction with, AP-CD/LD (CGI, GSS)

Secondary Outcomes (3)

• Quality of Life questionnaires

• Daytime sleepiness

• Efficacy measures of motor symptoms

Study Arms (1)

Extension

EXPERIMENTAL

Open label extension, 1 arm

Drug: AP-CD/LD

Interventions

AP-CD/LD DRUG

Extension

Eligibility Criteria

• Age: 30 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject satisfactorily completed study IN 09 004 and, in the opinion of the investigator, will benefit from participation in the extension study
• Subject with Parkinson's disease experiencing predictable motor fluctuations, end of dose "wearing off", defined by the patient's report of at least two episodes daily of a decline in function from peak benefit, with at least 2 hours OFF a day at the discretion of the PI (does not include early morning akinesia or nocturnal akinesia)
• Subject that has been treated for at least 3 months prior to the study with 500-1000 mg Levodopa + DDCI, in 4 or more divided doses per day
• Hoehn and Yahr stages I-III
• Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study
• Prepared and able to give written (signed and dated) informed consent, which includes compliance with study requirements and restrictions prior to admission to the study.

You may not qualify if:

• Subject has undergone Deep brain stimulation (DBS) or any other neurological surgical procedure that affects neurological symptoms (e.g tremor, rigidity, stiffness, slowed movement, and walking problem)
• Subjects with any gastrointestinal surgery other than appendectomy or herniotomy, recent history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, intestinal obstruction, or frequent nausea or emesis or diarrhea which, in the opinion of the investigator, contraindicates his/her participation
• Subjects with a recent history of clinically defined GERD, peptic ulcer or any gastrointestinal disorder likely to influence drug absorption which, in the opinion of the investigator, contraindicates his/her participation

Sponsors & Collaborators

• Intec Pharma Ltd.: lead

Study Sites (5)

Rambam Medical Center

Haifa, Israel

Location

Wolfson Medical Center

Holon, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

TASMC

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2009
• First Posted: July 27, 2009
• Study Start: August 1, 2012
• Primary Completion: August 1, 2012
• Last Updated: November 24, 2015

Record last verified: 2012-09

Locations

IL (5)